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New treatment option for Parkinson Disease
Official title Exercise & Brain Energetics in PD
ClinicalTrials.gov ID: NCT04426786
What this study is testing
- What it's testing
- There is increasing evidence that the usage and delivery of energy to the brain, known as brain energetics, is altered in people with Parkinson's disease (PD). This project will explore whether exercise has a positive impact on brain energetics using functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) brain scanning in PD subjects.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of people with a family history)
- Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
- Currently exercise less than 120 minutes per week (PD non-exercisers) General
You likely can't join if
- atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- significant osteoporosis or arthritis;
- history of cancer within 5 years of study participation;
- high dose of radiation from other procedures within the year;
- not able to tolerate being off PD medication for up to 24 hours;
- a female subject who is breast-feeding or pregnant;
See the full eligibility criteria
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of people with a family history)
- Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
- Currently exercise less than 120 minutes per week (PD non-exercisers) General
- atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- significant osteoporosis or arthritis;
- history of cancer within 5 years of study participation;
- high dose of radiation from other procedures within the year;
- not able to tolerate being off PD medication for up to 24 hours;
- a female subject who is breast-feeding or pregnant;
- current or past substance use problems;
- serious head injury with loss of consciousness for ≥ 5 minutes;
- people with other chronic diseases such as diabetes, kidney problems, high blood pressure, other known neurological disorders, or heart diseases;
- people who report having a significant respiratory disorder (e.g. asthma, chronic obstructive pulmonary disease (COPD)) or using home oxygen will be excluded to avoid discomfort or breathing difficulties from...
- current or past neurological disorder (e.g. strokes, seizures, neurodegenerative disease other than Parkinson's disease);
- current or past psychiatric disorders (e.g. depression, anxiety disorders);
- severe claustrophobia (a fear of closed in spaces);
- weight of more than 158kg (347 lbs);
- inability to lay still for up to 90 minutes;
- are not medically cleared to exercise;
- certain medications or conditions may impact participant's ability to participate and these will be discussed on a case by case basis with the participant and the study team. MRI-specific exclusion criteria:
- Machinist or metalworkers;
- cardiac pacemakers, wires, or defibrillator;
- past injury where a piece of metal lodged in your eye or orbit;
- ferromagnetic aneurysm clip;
- artificial heart valve;
- electrical stimulator for nerves or bones;
- ear or eye implant;
- implanted drug infusion pump;
- coil, catheter, or filter in any blood vessel;
- orthopedic hardware (artificial joint, plate, screws);
- other metallic prostheses;
- shrapnel, bullets, or other metal fragments;
- dentures, braces, or retainer;
- surgery (brain or otherwise), tattoos, or injection into a joint in the last 6 weeks;
- pierced body parts (other than earrings) or tattooed eyeliner;
- non-MRI safe intrauterine device (IUD). people may be excluded following study enrollment if they meet any of the following exclusion criteria:
- significant cognitive impairment or depression;
- significant or unstable cardiovascular or respiratory disease - all people will undergo a screening aerobic exercise test;
- failure to comply with the exercise intervention program by not completing at least 60 of the 72 exercise classes.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.